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Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT04049396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-08-08

No results posted yet for this study

Summary

Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses. The disease is associated with a group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity, hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver function and metabolic profiles of patients with NAFLD. In this context,A six week, open-label randomized controlled trial was conducted in a single medical center at Takestan Hospital, Iran. A total of 281 patients with NAFLD were enrolled and randomly assigned to treatment arm with (n=24) or without (n=24) berberine. All patients had received pre-randomization lifestyle training including recommendations on low-fat diet. Blood examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the beginning of the study and upon the completion of the trial (day 45). To assess tolerability of the study intervention and any possible adverse events, patients in both groups were required to attend weekly follow-up visits.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

OTHER

Berberine

24 Patient consumed 6,25 g/day Berberine for 6 weeks

Sponsors & Collaborators

  • Lida Nejati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-03-25
Completion
2019-06-15

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049396 on ClinicalTrials.gov